LEVETIRACETAM

Product NDC: 55488-0519
11-digit product format: 554880519
Labeler code: 55488
Product ID: 55488-0519_7ccdb5b2-160c-44eb-bbc3-b869e5323754
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LEVETIRACETAM
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Changzhou Pharmaceutical Factory
Application: ANDA212688
Marketing category: ANDA
Marketing start: 2020-06-11
Marketing end: 0000-00-00
Substance: LEVETIRACETAM
Active strength: 750 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55488-0519		I	Inactivated by FDA		2026-09-09
excluded package	package	55488-0519	55488-0519-1	I	Inactivated by FDA		2026-09-09

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55488-0519-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55488-0519-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55488-0519-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55488-0519-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55488-0519-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55488-0519-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55488-0519-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55488-0519-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55488-0519-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55488-0519-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55488-0519-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55488-0519-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55488-0519-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55488-0519-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55488-0519-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55488-0519-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55488-0519-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55488-0519-1	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212688-001	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-06-11
A212688-002	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2023-05-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A212688-001	AB
A212688-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 61 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212688-002	LEVETIRACETAM	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL		2020-06-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212688-001	LEVETIRACETAM	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-06-11	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 59 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212688-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212688-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212688-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212688-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212688-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212688-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212688-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212688-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212688-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212688-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212688-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212688-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212688-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212688-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212688-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212688-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212688-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212688-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212688-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212688-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212688-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212688-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212688-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212688-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212688-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212688-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212688-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212688-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212688-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212688-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212688-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212688-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212688-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212688-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212688-001	AB	1	`782e0a99824c…`
2020-12-22 03:56 UTC	2020-12	A212688-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212688-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212688-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212688-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212688-001	AB	1	`1c564ffb4f44…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
76e81f18-c6b9-f226-530a-a6296d5cd5f4	Product name	6	20251106
087c9486-f4a9-a565-c6fb-d6fa49f4572a	Product name	6	20230317
525a8d4d-1988-fc3f-e292-27fd384de4f0	Product name	8	20230104
32b651f8-caa7-6882-11c7-54c4ad21796b	Product name	8	20201216
ce453ca5-90cf-41ed-9de4-de519f70a0f2	Product name	2	20160303
66666eb8-1fa6-4a60-bae9-e564e73b4cd5	Product name	1	20150728
eecbc0ef-ab5c-4ff9-8aaa-6ea73ee46477	Product name	1	20150410

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55488-0519-1	2022-01-28	C162847	48780-1	d6a99b39-8f26-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use LEVETIRACETAM EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for LEVETIRACETAM EXTENDED-RELEASE TABLETS. LEVETIRACETAM extended-release tablets, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55488-0519-1	LEVETIRACETAMExtended-release	60 in 1 BOTTLE	TABLET, EXTENDED RELEASE	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55488-0519	LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM) TABLET, EXTENDED RELEASE [CHANGZHOU PHARMACEUTICAL FACTORY]	3	Legacy NDC, 1 package rows	20200625_5d3ce612-94de-4ad3-b873-27cb09304d45.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVETIRACETAM Extended-release	LEVETIRACETAM	Omnivium Pharmaceuticals LLC	1a31134d-6b63-4d14-8445-0ed132e6c88d	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212688 application number: ANDA212688

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
44YRR34555	LEVETIRACETAM	102767-28-2	LEVETIRACETAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
846378	levETIRAcetam 750 MG 24HR Extended Release Oral Tablet	PSN	5d3ce612-94de-4ad3-b873-27cb09304d45	3
846378	24 HR levetiracetam 750 MG Extended Release Oral Tablet	SCD	5d3ce612-94de-4ad3-b873-27cb09304d45	3
846378	levetiracetam 750 MG 24 HR Extended Release Oral Tablet	SY	5d3ce612-94de-4ad3-b873-27cb09304d45	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55488-0519-1	55488051901	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55488-0519-1)	2020-06-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LEVETIRACETAM Extended-release	Changzhou Pharmaceutical Factory \| Overseas Pharmaceuticals, Ltd. \| Neuland Laboratories Limited, Unit 1 \| Neuland Laboratories Limited, Unit 2	2020-06-23	Human Prescription Drug Label	3